PES to Avoid Extubation Failure in Intubated Stroke Patients at High Risk of Severe Dysphagia

NCT ID: NCT04010617

Last Updated: 2019-07-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-01
• Study Completion Date: 2019-12-31

Brief Summary

Post-extubation dysphagia (PED) recently became a growing concern as a major risk factor for extubation failure and significant contributor to poor patient outcomes with prevalence rates ranging from 12% to 69%, being highest in neurological patients (93%).

Pharyngeal electrical stimulation (PES) has been shown to improve airway safety and swallowing function tracheostomized stroke patients, thereby enhancing decannulation in this patient cohort.

In the present study the investigators evaluate whether PES is safe, feasible and effective in orotracheal intubated stroke patients at high risk of extubation failure.

Detailed Description

Endotracheal intubation and mechanical ventilation are common procedures for critically ill stroke patients. Although necessary and life-saving, timely extubation after ventilator weaning is desirable, because patients with delayed extubation experience higher pneumonia rate, increased need for tracheostomy, longer length of stay on the intensive care unit and higher mortality. On the other hand, extubation failure (EF) and subsequent need for emergent re-intubation is associated with similar sequelae.

Post-extubation dysphagia (PED) became a growing concern as a major risk factor for EF and significant contributor to poor patient outcomes with prevalence rates ranging from 12% to 69%, being highest in neurological patients (93%). Damage to the central swallowing network itself is the primary cause of PED in cerebrovascular disease, which constitutes the leading diagnosis on neuro-ICUs. Further mechanisms include pharyngolaryngeal lesions caused by the tube, critical illness neuropathy and myopathy leading to muscle weakness and dyscoordination of breathing and swallowing, and an impaired sensation due to sedation, mucosal damage, or the underlying critical illness itself. As a consequence reintubation rates in neurological collectives are as high as 20 to 40%.

Pharyngeal electrical stimulation (PES) has been shown to improve airway safety and swallowing function tracheostomized stroke patients, thereby enhancing decannulation in this patient cohort.

In the present study the investigators evaluate whether PES is safe, feasible and effective in orotracheal intubated stroke patients at high risk of extubation failure.

Conditions

Stroke; Dysphagia; Extubation Failure

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Pharyngeal Electrical Stimulation

Orotracheal intubated patients at high risk of extubation failure will receive open-label PES

Group Type: EXPERIMENTAL

Pharyngeal Electrical Stimulation (PES)

Intervention Type: DEVICE

PES will be delivered by a commercial device (Phagenyx, Phagenesis Ltd, Manchester, UK), which comprises a nasogastric feeding catheter that houses stimulation ring-electrodes and a computerised base station that delivers stimulation in the range 1-50 mA at 5 Hz.

Interventions

Pharyngeal Electrical Stimulation (PES)

PES will be delivered by a commercial device (Phagenyx, Phagenesis Ltd, Manchester, UK), which comprises a nasogastric feeding catheter that houses stimulation ring-electrodes and a computerised base station that delivers stimulation in the range 1-50 mA at 5 Hz.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

Acute stroke orotracheal intubation high-risk of extubation failure (DEFISS-score ≥4) successful respiratory weaning according to the treating intensivist within 24 to 72 hours

Exclusion Criteria

Patients are excluded from study participation if any of the following apply:

• Suffer from pre-existing neurogenic dysphagia or a condition that can cause dysphagia (for example Parkinson's Disease);
• Suffer from non-neurogenic dysphagia (e.g. cancer);
• Suffer from neuromuscular disorders (e.g. myasthenia gravis, motor neuron disease);
• Participate in any other study potentially influencing the outcome of PES, both medicinal or medical device product related and for which the patient signed a consent form for his/her study participation;
• Receive or have received within one month prior to the intended PES treatment any other type of standard cranial or percutaneous electrical stimulation therapy to treat dysphagia;
• Have a pacemaker or an implantable defibrillator;
• Have a nasal anatomical deformity, nasal airway obstruction, have had oesophageal surgery or any other circumstance where placement of a standard NG feeding tube would be deemed unsafe;
• Have a cardiac or respiratory condition that might render the insertion of the catheter into the throat unsafe;
• Are pregnant or nursing women;

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital Muenster

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rainer Dziewas, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Neurology, University Hospital Münster, Germany

Locations

University Hospital Münster, Deparment of Neurology

Münster, , Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Rainer Dziewas, MD

Role: CONTACT

dziewas@uni-muenster.de

+49251834 ext. 8239

Sonja Suntrup-Krueger, MD

Role: CONTACT

sonja.suntrup-krueger@ukmuenster.de

+49251834 ext. 1127

Facility Contacts

Rainer Dziewas, MD

Role: primary

dziewas@uni-muenster.de

+49251834 ext. 8239

Sonja Suntrup-Krueger, MD

Role: backup

sonja.suntrup-krueger@ukmuenster.de

+49251834 ext. 1127

Other Identifiers

01072018

Identifier Type: -

Identifier Source: org_study_id